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1 . 2023

Transcatheter implantation of a self-expanding pulmonary valve in animal experiment

Abstract

Background. Obstruction of the outlet of the right ventricle occurs in such congenital heart defects as tetrad of Fallot, atresia or stenosis of the pulmonary artery and other anomalies of the conotruncus. As the child grows, several repeated open interventions are required due to the discrepancy in the size of the “prosthesis–patient”. However, repeated prosthetics in conditions of artificial circulation is associated with a high risk of complications. An alternative to this approach has become transcatheter technologies for implantation of the PA valve. Currently, there are 2 types of balloon expansion valves Melody (Medtronic) and SAPIEN (Edwards LifeSciences). These bioprostheses are intended for implantation into the trunk/“neotrunk” of the PA, what makes them practically useless when combined with dysfunction of the trunk and distal/proximal parts.

Aim. To determine possible intra- and postoperative complications associated with valve implantation and to evaluate the safety and effectiveness of transcatheter implantation of a self-opening pulmonary artery valve.

Material and methods. In total, 5 male pigs of the breed “mini pig” were operated. For transcatheter implantation, a self-opening valve developed in the Meshalkin National Medical Research Center, Ministry of Health of Russian Federation was used, the frame of which is made of nitinol with a “memory effect”. The flap apparatus is made of pork pericardium. The path of the guide during the valve implantation procedure is described as follows: the right femoral vein in the first, third, fourth and fifth experiments, the right jugular vein in the second experiment – the inferior vena cava – the right atrium – the right ventricle – the pulmonary artery – the distal part of the left pulmonary artery.

Results. In 3 of 5 cases valve implantation was successful. In the first  case, the animal had a dislocation of the valve into the trunk of the pulmonary artery during its implantation. In the second case, when trying to carry out the delivery system with access through the right jugular vein, the trunk of the pulmonary artery ruptured, which led to the development of tamponade and the death of the animal on the operating table. Transesophageal echocardiography performed immediately after valve implantation showed the absence of regurgitation on the transcatheter valve in 3 animals and 1 animal with dislocation of the transcatheter valve had a 2 mm paroprosthetic fistula. The average pressure gradient on the transcatheter valve was 8 (6; 10) mm Hg. In 6 months of follow up, according to the ECG data, no negative dynamics was detected in 3 animals. In an animal with a dislocation of the transcatheter valve, paraprosthetic regurgitation increased to 2 art., the gradient on the transcatheter valve was 32 (average – 18) mm Hg, while the contractility of the right and left ventricles was preserved. When examined after 12 months, according to angiography data, the correct position of the transcatheter valve was noted in 3 animals, the peak pressure in the right ventricle was 35 (32; 38) mm Hg, the gradient on the transcatheter valve was 7 (5; 9) mm Hg. Deformations of the pulmonary arteries were not revealed. In an animal with a dislocation of the transcatheter valve, the peak pressure in the right ventricle was 49 mm Hg, the gradient on the valve was 29 mm Hg. Microscopic assessment showed no cellular infiltration or structural damage to the valves. No signs of calcification of the leaf apparatus after staining by the von Koss method were found.

Conclusion. Transcatheter implanted valves proved successful in 3 out of 5 laboratory animals. Short-term follow-up after surgery showed the safety and effectiveness of the implanted device.

Keywords:right ventricular outlet; self-opening valve; transcatheter implantation

Funding. This work was supported by a grant from the Russian Science Foundation, project No. 21-75-10041.
Conflict of interest. The authors declare no conflict of interest.
For citation: Rzaeva K.A., Timchenko T.P., Zhuravleva I.Yu., Arkhipov A.N., Gorbatykh A.V., Voitov A.V., Bogachev-Prokophiev A.V., Soynov I.A. Transcatheter implantation of a self-expanding pulmonary valve in animal experiment. Clinical and Experimental Surgery. Petrovsky Journal. 2023; 11 (1): 47–53. DOI: https://doi.org/10.33029/2308-1198-2023-11-1-47-53  (in Russian)

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CHIEF EDITOR
CHIEF EDITOR
Sergey L. Dzemeshkevich
MD, Professor (Moscow, Russia)

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